RTA 408 Capsules in Patients With Melanoma - REVEAL

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

May 9, 2018

Study Completion Date

July 23, 2018

Conditions
MelanomaUnresectable (Stage III) MelanomaMetastatic (Stage IV) Melanoma
Interventions
DRUG

Omaveloxolone Capsules (2.5 mg/capsule)

Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label

DRUG

Ipilimumab (3 mg/kg)

Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg

DRUG

Nivolumab (240 mg)

Sterile solution containing nivolumab to be delivered intravenously at 240 mg

DRUG

Omaveloxolone Capsules (10 mg/capsule)

Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label

DRUG

Omaveloxolone Capsules (50 mg/capsule)

Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label

Trial Locations (10)

19713

Christiana Hospital Helen F. Graham Cancer Center, Newark

20007

Goergetown-Lombardi Comprehensive Cancer Center, Washington D.C.

27710

Duke Cancer Institute, Durham

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

36608

Southern Cancer Center, Mobile

72703

Highlands Oncology Group, Fayetteville

77030

MD Anderson Cancer Center, Houston

80045

University of Colorado Cancer Center, Anschutz Cancer Pavilion, Aurora

02215

Dana Farber Cancer Institute, Boston

07960

Atlantic Melanoma Center, Morristown

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biogen

INDUSTRY